Apixaban for Prevention of Acute Ischemic Events - 2A Phase 3, Randomized, Double-Blind, Evaluation of the Safety and Efficacy of Apixaban In Subjects with a Recent Acute Coronary Syndrome+ Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific-Site (version 1.0, dated 17-Dec-08)Apixaban para la prevención de Acontecimientos Isquémicos Agudos - 2Estudio en fase 3, aleatorizado y doble ciego para evaluar la seguridad y eficacia de Apixaban en pacientes con síndrome coronario agudo reciente+Enmienda para la obtención de una muestra hematológica para estudios farmacogenéticos (versión 1.0, de fecha 17-Dic-08) - APPRAISE - 2

Conditions: Subjects with a recent acute coronary syndrome (ACS) and at least 2 additional risk factors for recurrent ischemic events.Sujetos con un Síndrome Coronario Agudo (SCA) reciente y, al menos, 2 elementos de riesgo adicionales para eventos isquémicos recurrentes.
MedDRA version: 9.1Level: LLTClassification code 10051592Term: Acute coronary syndrome

Registration Number: EUCTR2008-008298-77-ES

Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10800

Inclusion Criteria

1) Age ? 18 years
2) Written informed consent.
3) An acute coronary syndrome (ST-elevation or non-ST-elevation MI or UA) within 7 days characterized by:
a) symptoms of myocardial ischemia at rest lasting at least 10 minutes and either
b) elevation in cardiac biomarkers (troponin T or I or creatine kinase MB) above the local upper limit of normal)
or
c) dynamic ST-segment deviation (depression or elevation ? 0.1 mV (1.0 mm)
4) Completion of parenteral anticoagulation therapy for the index ACS event.
5) Clinically stable, receiving standard of care for ACS, including single (aspirin or a P2Y12 antagonist such as clopidogrel) or dual (aspirin plus a P2Y12 antagonist such as clopidogrel) antiplatelet therapy, at the discretion of the treating physician.
6) Two or more of the following risk factors
a) Age ? 65 years
b) Diabetes mellitus
c) Prior myocardial infarction (other than the qualifying event) within 5 years
d) Ischemic cerebrovascular disease (ischemic stroke or carotid endarterectomy)
e) Peripheral vascular disease (symptoms of claudication and/or peripheral revascularization, and/or ankle-brachial index (ABI) < 0.9)
f) Heart failure or left ventricular ejection fraction <40% associated with the index ACS event
g) Impaired renal function (calculated CrCl < 60 mL/min)
h) No revascularization for index ACS event
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Persistent severe hypertension (SBP ? 180 mmHg or DBP ? 110 mmHg)
2) Calculated CrCl < 20 mL/min or on dialysis for end-stage renal disease
3) Active bleeding or high risk for bleeding (eg, active peptic ulcer disease, other gastrointestinal pathology with a raised risk of bleeding, liver cirrhosis, malignancies with a raised risk of bleeding)
4) Known coagulopathy
5) Acute pericarditis
6) Recent (< 7 days) ischemic stroke
7) NYHA Class IV heart failure at time of randomization
8) Any history of intracranial bleeding
9) Active and/or significant, known hepatobiliary disease
10) Hemoglobin < 9 g/dl
11) Platelet count < 100,000 mm³
12) Required ongoing treatment with a parenteral or chronic oral anticoagulation (eg, mechanical valve, recent DVT or pulmonary embolism, known left ventricular thrombus)
13) Required ongoing treatment with aspirin > 325 mg daily
14) Required ongoing treatment with a strong inhibitor of CYP3A4 [azole antifungals (itraconazole and ketoconazole)], macrolide antibiotics (clarithromycin and telithromycin), protease inhibitors [(ritonavir, indinavir, nelfinavir, atazanavir, and saquinavir), and nefazadone)]
15) Subjects who participated previously in any other study involving apixaban
16) Severe comorbid condition with life expectancy of ? 6 months
17) Inability to follow the protocol
18) Use of an investigational drug or device within 30 days
19) Women who are pregnant, breastfeeding, or of childbearing potential and unwilling or unable to use an acceptable method of birth control to avoid pregnancy.
20) Prisoners or subjects who are involuntarily incarcerated
21) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness